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Health Canada Grants Market Authorization for KALYDECO® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 2 Months and Older
Health Canada Grants Market Authorization for KALYDECO® (ivacaftor) for Eligible Children Wi...
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[{"type":"text","content":"\n \n \n \n Health Canada Grants Market Authorization for KALYDECO® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 2 Months and Older\n \n \n /* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n \n \n \n \n \n \n Canada NewsWire\n \n \n \n \n \n \n TORONTO\n \n \n ,\n \n \n Nov. 29, 2023\n \n \n /CNW/ -\n \n \n Vertex Pharmaceuticals Incorporated\n \n \n (Nasdaq: VRTX) today announced that Health Canada has granted Market Authorization for the expanded use of\n \n Pr\n \n KALYDECO\n \n ®\n \n (ivacaftor) for the treatment of cystic fibrosis (CF) in children ages 2 months and older weighing at least 3 kg who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (\n \n CFTR\n \n ) gene:\n \n G551D\n \n ,\n \n G1244E\n \n ,\n \n G1349D\n \n ,\n \n G178R\n \n ,\n \n G551S\n \n ,\n \n S1251N\n \n ,\n \n S1255P\n \n ,\n \n S549N\n \n \n ,\n \n \n S549R or R117H.\n \n \n \n \n \n \n \n \n \n \n \"For the first time, children with specific mutations will be eligible at 2 months of age for a medicine that treats the underlying cause of their cystic fibrosis,\" said\n \n Michael Siauw\n \n , General Manager at Vertex Pharmaceuticals (\n \n Canada\n \n ) Incorporated. \"We remain committed to researching and developing medicines for younger CF patients, and this important approval highlights our continued dedication and progress.\"\n \n \n Vertex will work closely with government and private payers to facilitate access for eligible patients as soon as possible.\n \n \n \n Pr\n \n KALYDECO\n \n ®\n \n was previously approved by Health Canada for use in people with CF ages 4 months and older who have one of the following mutations in the\n \n CFTR\n \n gene:\n \n G551D\n \n ,\n \n G1244E\n \n ,\n \n G1349D\n \n ,\n \n G178R\n \n ,\n \n G551S\n \n ,\n \n S1251N\n \n ,\n \n S1255P\n \n ,\n \n S549N\n \n ,\n \n S549R or R117H\n \n .\n \n \n \n About Cystic Fibrosis\n \n \n \n Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 88,000 people globally. CF is a progressive, multi-organ disease ...